Latest news with #ReAltaLifeSciences
Yahoo
19-05-2025
- Health
- Yahoo
ReAlta Life Sciences Announces New Inflammatory Biomarker Data from Acute Exacerbations of Chronic Obstructive Pulmonary Disease Program at American Thoracic Society 2025 International Conference
NORFOLK, Va., May 19, 2025--(BUSINESS WIRE)--ReAlta Life Sciences, Inc. ("ReAlta" or the "Company"), a clinical-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address rare and acute inflammatory diseases, today announced a poster presentation featuring new analysis of clinical data from its acute exacerbations of chronic obstructive pulmonary disease (AE-COPD) program at the American Thoracic Society (ATS) 2025 International Conference, taking place May 18-21, 2025 in San Francisco. The new findings, presented today in a poster titled "Effect of RLS-0071 on Airway Neutrophilia Following Inhaled Endotoxin Challenge Assessed by ChipCytometry," were from additional analysis of samples from ReAlta's previously reported Phase 1b study of RLS-0071 (pegtarazimod). Pegtarazimod is a 15-amino-acid peptide that uniquely targets both humoral and cellular inflammation. The analysis, conducted using ChipCytometry, extends the original proof-of-mechanism findings regarding inhibition of lung neutrophils and inflammatory cytokines, and reveals cellular-level mechanisms. Airway neutrophilia is associated with several lung diseases, including acute exacerbations of COPD and severe asthma, and related lung damage is a result of neutrophil-mediated release of toxic myeloperoxidase (MPO) and neutrophil elastase (NE). In this ChipCytometry analysis, pegtarazimod prevented lipopolysaccharide (LPS)-driven increases in neutrophil activation markers (CD89, CD11a, CD11b) as well as intracellular levels of MPO and NE. In ReAlta's Phase 1b study, healthy participants received inhaled LPS to induce temporary neutrophil-mediated inflammation in the lungs, followed by intravenous administration of pegtarazimod at different dose levels. Pegtarazimod demonstrated powerful inhibition of neutrophil migration into the lungs by half (~50%), with significant reductions in key inflammatory markers including MPO and NE, and pro-inflammatory cytokines IL-1β and IL-8. "These new data further reinforce pegtarazimod's potential to address neutrophil-driven inflammation in the lungs by meaningfully reducing detrimental neutrophil activation," said Kenji M. Cunnion, MD, MPH, Chief Medical Officer at ReAlta. "We look forward to completing our Phase 2 trial in patients with AE-COPD (NCT06175065) later this year and exploring opportunities for our novel dual-targeting peptide platform to deliver effective new therapies for respiratory diseases." Prof. Dr. Jens M. Hohlfeld, Division Director of Airway Research at the Fraunhofer Institute for Toxicology and Experimental Medicine in Hannover, Germany and lead investigator for the study, commented, "ChipCytometry analysis offers various advantages over conventional flow cytometry and differential cell counts that allowed us to visualize how pegtarazimod impacts neutrophil activation markers and intracellular components, which had not been directly observable in our previous analyses. These new insights into pegtarazimod's cellular-level mechanisms of action strengthen the scientific foundation for its development and will inform other upcoming clinical trials in patients with neutrophil-driven inflammatory conditions." About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a clinical mid-stage biopharmaceutical company dedicated to addressing life threatening rare and acute inflammatory diseases by rebalancing the inflammatory response. The Company's EPICC peptide platform leverages discoveries from the human astrovirus (HAstV-1), which uniquely inhibits components of the innate immune system. ReAlta's therapeutic peptides employ the dual-targeting mechanisms of HAstV-1 to modulate both complement and innate inflammatory pathways by inhibiting complement cascade activation and two key neutrophil-driven mechanisms: myeloperoxidase (MPO) and neutrophil extracellular traps (NETs). The Company's lead candidate, RLS-0071 (pegtarazimod), has received FDA Orphan Drug Designation and Fast Track Designations for hypoxic ischemic encephalopathy (HIE), a devastating disease that causes brain damage and high mortality in oxygen-deprived newborns; Orphan Drug Designation by the European Medicines Agency for HIE; FDA Orphan Drug and Fast Track Designations for acute graft-versus-host disease (aGvHD) associated with bone marrow and stem cell transplants; and FDA IND clearance for acute exacerbations of chronic obstructive pulmonary disease (COPD). Founded in 2018, ReAlta operates in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit View source version on Contacts Investors John RickmanChief Financial Officerjrickman@ Media Harrison WongICR HealthcareReAltaPR@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
19-05-2025
- Health
- Yahoo
ReAlta Life Sciences Announces New Inflammatory Biomarker Data from Acute Exacerbations of Chronic Obstructive Pulmonary Disease Program at American Thoracic Society 2025 International Conference
NORFOLK, Va., May 19, 2025--(BUSINESS WIRE)--ReAlta Life Sciences, Inc. ("ReAlta" or the "Company"), a clinical-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address rare and acute inflammatory diseases, today announced a poster presentation featuring new analysis of clinical data from its acute exacerbations of chronic obstructive pulmonary disease (AE-COPD) program at the American Thoracic Society (ATS) 2025 International Conference, taking place May 18-21, 2025 in San Francisco. The new findings, presented today in a poster titled "Effect of RLS-0071 on Airway Neutrophilia Following Inhaled Endotoxin Challenge Assessed by ChipCytometry," were from additional analysis of samples from ReAlta's previously reported Phase 1b study of RLS-0071 (pegtarazimod). Pegtarazimod is a 15-amino-acid peptide that uniquely targets both humoral and cellular inflammation. The analysis, conducted using ChipCytometry, extends the original proof-of-mechanism findings regarding inhibition of lung neutrophils and inflammatory cytokines, and reveals cellular-level mechanisms. Airway neutrophilia is associated with several lung diseases, including acute exacerbations of COPD and severe asthma, and related lung damage is a result of neutrophil-mediated release of toxic myeloperoxidase (MPO) and neutrophil elastase (NE). In this ChipCytometry analysis, pegtarazimod prevented lipopolysaccharide (LPS)-driven increases in neutrophil activation markers (CD89, CD11a, CD11b) as well as intracellular levels of MPO and NE. In ReAlta's Phase 1b study, healthy participants received inhaled LPS to induce temporary neutrophil-mediated inflammation in the lungs, followed by intravenous administration of pegtarazimod at different dose levels. Pegtarazimod demonstrated powerful inhibition of neutrophil migration into the lungs by half (~50%), with significant reductions in key inflammatory markers including MPO and NE, and pro-inflammatory cytokines IL-1β and IL-8. "These new data further reinforce pegtarazimod's potential to address neutrophil-driven inflammation in the lungs by meaningfully reducing detrimental neutrophil activation," said Kenji M. Cunnion, MD, MPH, Chief Medical Officer at ReAlta. "We look forward to completing our Phase 2 trial in patients with AE-COPD (NCT06175065) later this year and exploring opportunities for our novel dual-targeting peptide platform to deliver effective new therapies for respiratory diseases." Prof. Dr. Jens M. Hohlfeld, Division Director of Airway Research at the Fraunhofer Institute for Toxicology and Experimental Medicine in Hannover, Germany and lead investigator for the study, commented, "ChipCytometry analysis offers various advantages over conventional flow cytometry and differential cell counts that allowed us to visualize how pegtarazimod impacts neutrophil activation markers and intracellular components, which had not been directly observable in our previous analyses. These new insights into pegtarazimod's cellular-level mechanisms of action strengthen the scientific foundation for its development and will inform other upcoming clinical trials in patients with neutrophil-driven inflammatory conditions." About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a clinical mid-stage biopharmaceutical company dedicated to addressing life threatening rare and acute inflammatory diseases by rebalancing the inflammatory response. The Company's EPICC peptide platform leverages discoveries from the human astrovirus (HAstV-1), which uniquely inhibits components of the innate immune system. ReAlta's therapeutic peptides employ the dual-targeting mechanisms of HAstV-1 to modulate both complement and innate inflammatory pathways by inhibiting complement cascade activation and two key neutrophil-driven mechanisms: myeloperoxidase (MPO) and neutrophil extracellular traps (NETs). The Company's lead candidate, RLS-0071 (pegtarazimod), has received FDA Orphan Drug Designation and Fast Track Designations for hypoxic ischemic encephalopathy (HIE), a devastating disease that causes brain damage and high mortality in oxygen-deprived newborns; Orphan Drug Designation by the European Medicines Agency for HIE; FDA Orphan Drug and Fast Track Designations for acute graft-versus-host disease (aGvHD) associated with bone marrow and stem cell transplants; and FDA IND clearance for acute exacerbations of chronic obstructive pulmonary disease (COPD). Founded in 2018, ReAlta operates in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit View source version on Contacts Investors John RickmanChief Financial Officerjrickman@ Media Harrison WongICR HealthcareReAltaPR@ Sign in to access your portfolio
Business Wire
19-05-2025
- Health
- Business Wire
ReAlta Life Sciences Announces New Inflammatory Biomarker Data from Acute Exacerbations of Chronic Obstructive Pulmonary Disease Program at American Thoracic Society 2025 International Conference
NORFOLK, Va.--(BUSINESS WIRE)-- ReAlta Life Sciences, Inc. ('ReAlta' or the 'Company'), a clinical-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address rare and acute inflammatory diseases, today announced a poster presentation featuring new analysis of clinical data from its acute exacerbations of chronic obstructive pulmonary disease (AE-COPD) program at the American Thoracic Society (ATS) 2025 International Conference, taking place May 18-21, 2025 in San Francisco. The new findings, presented today in a poster titled ' Effect of RLS-0071 on Airway Neutrophilia Following Inhaled Endotoxin Challenge Assessed by ChipCytometry,' were from additional analysis of samples from ReAlta's previously reported Phase 1b study of RLS-0071 (pegtarazimod). Pegtarazimod is a 15-amino-acid peptide that uniquely targets both humoral and cellular inflammation. The analysis, conducted using ChipCytometry, extends the original proof-of-mechanism findings regarding inhibition of lung neutrophils and inflammatory cytokines, and reveals cellular-level mechanisms. Airway neutrophilia is associated with several lung diseases, including acute exacerbations of COPD and severe asthma, and related lung damage is a result of neutrophil-mediated release of toxic myeloperoxidase (MPO) and neutrophil elastase (NE). In this ChipCytometry analysis, pegtarazimod prevented lipopolysaccharide (LPS)-driven increases in neutrophil activation markers (CD89, CD11a, CD11b) as well as intracellular levels of MPO and NE. In ReAlta's Phase 1b study, healthy participants received inhaled LPS to induce temporary neutrophil-mediated inflammation in the lungs, followed by intravenous administration of pegtarazimod at different dose levels. Pegtarazimod demonstrated powerful inhibition of neutrophil migration into the lungs by half (~50%), with significant reductions in key inflammatory markers including MPO and NE, and pro-inflammatory cytokines IL-1β and IL-8. 'These new data further reinforce pegtarazimod's potential to address neutrophil-driven inflammation in the lungs by meaningfully reducing detrimental neutrophil activation,' said Kenji M. Cunnion, MD, MPH, Chief Medical Officer at ReAlta. 'We look forward to completing our Phase 2 trial in patients with AE-COPD (NCT06175065) later this year and exploring opportunities for our novel dual-targeting peptide platform to deliver effective new therapies for respiratory diseases.' Prof. Dr. Jens M. Hohlfeld, Division Director of Airway Research at the Fraunhofer Institute for Toxicology and Experimental Medicine in Hannover, Germany and lead investigator for the study, commented, 'ChipCytometry analysis offers various advantages over conventional flow cytometry and differential cell counts that allowed us to visualize how pegtarazimod impacts neutrophil activation markers and intracellular components, which had not been directly observable in our previous analyses. These new insights into pegtarazimod's cellular-level mechanisms of action strengthen the scientific foundation for its development and will inform other upcoming clinical trials in patients with neutrophil-driven inflammatory conditions.' About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a clinical mid-stage biopharmaceutical company dedicated to addressing life threatening rare and acute inflammatory diseases by rebalancing the inflammatory response. The Company's EPICC peptide platform leverages discoveries from the human astrovirus (HAstV-1), which uniquely inhibits components of the innate immune system. ReAlta's therapeutic peptides employ the dual-targeting mechanisms of HAstV-1 to modulate both complement and innate inflammatory pathways by inhibiting complement cascade activation and two key neutrophil-driven mechanisms: myeloperoxidase (MPO) and neutrophil extracellular traps (NETs). The Company's lead candidate, RLS-0071 (pegtarazimod), has received FDA Orphan Drug Designation and Fast Track Designations for hypoxic ischemic encephalopathy (HIE), a devastating disease that causes brain damage and high mortality in oxygen-deprived newborns; Orphan Drug Designation by the European Medicines Agency for HIE; FDA Orphan Drug and Fast Track Designations for acute graft-versus-host disease (aGvHD) associated with bone marrow and stem cell transplants; and FDA IND clearance for acute exacerbations of chronic obstructive pulmonary disease (COPD). Founded in 2018, ReAlta operates in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit
Yahoo
26-04-2025
- Health
- Yahoo
ReAlta Life Sciences Presents Data for Hypoxic Ischemic Encephalopathy at PAS Meeting 2025
By Karen Roman ReAlta Life Sciences said it is presenting new data from its hypoxic ischemic encephalopathy (HIE) program at the Pediatric Academic Societies Annual Meeting, taking place in Honolulu, Hawaii, from April 24-28, 2025. The findings confirm elevated inflammatory biomarkers in newborns with HIE and demonstrate a predictable way the body interacts with RLS-0071 (pegtarazimod), the company stated. 'These biomarker findings represent a significant advancement in our understanding of the inflammatory pathways driving HIE in humans,' said Kenji M. Cunnion, MD, MPH, ReAlta's Chief Medical Officer. Contact: Editor@
Business Wire
25-04-2025
- Health
- Business Wire
ReAlta Life Sciences Announces New Clinical Data for RLS-0071 (pegtarazimod) from Hypoxic Ischemic Encephalopathy Program at Pediatric Academic Societies 2025 Meeting
NORFOLK, Va.--(BUSINESS WIRE)-- ReAlta Life Sciences, Inc. ('ReAlta' or the 'Company'), a clinical-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address rare and acute inflammatory diseases, today announced new clinical data from its hypoxic ischemic encephalopathy (HIE) program, to be presented at the Pediatric Academic Societies (PAS) Annual Meeting, taking place April 24-28, 2025 in Honolulu, Hawaii. First Human Evidence of Predicted Inflammatory Mechanisms in HIE Aligned with RLS-0071 Mechanism of Action Poster Presentation: 'Early Granulocyte Inflammatory Biomarkers in Newborn Babies with Moderate or Severe Hypoxic Ischemic Encephalopathy' Biomarker data from the ongoing Phase 2 STAR trial provide the first confirmatory evidence in humans of inflammatory mechanisms previously observed only in animal models of HIE. The findings show elevated levels of myeloperoxidase (MPO) in newborns with HIE, as predicted, with generally higher levels observed in those with severe versus moderate cases. These data validate a critical component of the disease process. Extracellular MPO contributes to brain tissue damage in two distinct ways: direct tissue injury through hypochlorous acid generation and activation of neutrophils and microglia to a pro-inflammatory state, leading to the formation of extracellular traps that further contribute to tissue damage. The formation of extracellular traps is supported by finding elevated cell-free DNA in the plasma of many of these babies. 'These biomarker findings represent a significant advancement in our understanding of the inflammatory pathways driving HIE in humans,' said Kenji M. Cunnion, MD, MPH, Chief Medical Officer at ReAlta. 'This is the first clinical evidence linking MPO-driven mechanisms in HIE, validating a key component of the disease process. These insights strongly support the rationale for targeting MPO and neutrophil activation with RLS-0071 (pegtarazimod). Pegtarazimod is designed to inhibit these processes, including neutrophil and microglia activation and extracellular trap formation, and these data suggest that our mechanism is well positioned to address these two drivers of inflammation and tissue damage in HIE.' Predictable Pharmacokinetic Profile in Vulnerable Newborn Population Poster Presentation: 'Pharmacokinetics of RLS-0071, a Novel Anti-Inflammatory Peptide, in Newborns With Moderate or Severe Hypoxic Ischemic Encephalopathy' In pharmacokinetic (PK) data from the first two dosing cohorts of the STAR trial, RLS-0071 (pegtarazimod) at both 3 mg/kg and 10 mg/kg dose levels demonstrates highly consistent results with pre-clinical PK models and adult humans. This is a particularly notable achievement in a newborn population, where PK profiles often vary due to rapid physiological changes. ReAlta's PK modeling and planned dose levels are effectively translating into the targeted patient population, with plasma concentrations remaining within previously established safety parameters. 'The data being presented at PAS advance both our understanding of the disease and the strong potential of pegtarazimod in treating newborns with HIE,' said Paolo Martini, PhD, Chief Research & Development Officer of ReAlta. 'We are encouraged by the consistency of the pharmacokinetics and the emerging biomarker data. Together, these results reinforce our confidence in pegtarazimod's innovative dual-targeting mechanism and its potential to address significant unmet needs in HIE, where no approved pharmacological treatments currently exist beyond therapeutic hypothermia.' About the STAR Trial and RLS-0071 (pegtarazimod) The STAR trial (NCT05778188) is a two-stage, randomized, double-blind, placebo-controlled study currently enrolling patients across 13 NICUs in the United States, evaluating RLS-0071 (pegtarazimod) in newborns with moderate or severe HIE undergoing therapeutic hypothermia. Pegtarazimod is a 15-amino-acid peptide that uniquely targets both humoral and cellular inflammation and is the Company's lead therapeutic candidate for HIE treatment. The peptide works by inhibiting complement activation at C1, as well as myeloperoxidase activity and extracellular trap formation – key mechanisms implicated in the inflammatory cascade of reperfusion injury that contributes to brain damage in HIE. About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a clinical mid-stage biopharmaceutical company dedicated to addressing life threatening rare and acute inflammatory diseases by rebalancing the inflammatory response. The Company's EPICC peptide platform leverages discoveries from the human astrovirus (HAstV-1), which uniquely inhibits components of the innate immune system. ReAlta's therapeutic peptides employ the dual-targeting mechanisms of HAstV-1 to modulate both complement and innate inflammatory pathways by inhibiting complement cascade activation and two key neutrophil-driven mechanisms: myeloperoxidase (MPO) and neutrophil extracellular traps (NETs). The Company's lead candidate, RLS-0071 (pegtarazimod), has received FDA Orphan Drug Designation and Fast Track Designations for hypoxic ischemic encephalopathy (HIE), a devastating disease that causes brain damage and high mortality in oxygen-deprived newborns; Orphan Drug Designation by the European Medicines Agency for HIE; FDA Orphan Drug and Fast Track Designations for acute graft-versus-host disease (aGvHD) associated with bone marrow and stem cell transplants; and FDA IND clearance for acute exacerbations of chronic obstructive pulmonary disease (COPD). Founded in 2018, ReAlta operates in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit
